FDA notifies Invivyd that Pemgarda EUA will end June 2027

Invivyd, Inc. (Nasdaq: IVVD) announced that the U.S. Food and Drug Administration has issued a Notice of Termination for the Emergency Use Authorization (EUA) of its COVID-19 prevention drug Pemgarda (pemivibart), with an effective termination date of June 29, 2027.

The notice follows a June 30, 2026 announcement by the U.S. Department of Health and Human Services that it would terminate the COVID-19 EUA declaration, also effective June 29, 2027, providing a twelve-month transition period.

Pemgarda has been authorized under an EUA since March 2024 for pre-exposure prophylaxis of COVID-19 in adults and adolescents with moderate-to-severe immune compromise who are unlikely to mount an adequate immune response to COVID-19 vaccination.

Invivyd said it is in dialogue with the FDA about next steps following the EUA termination notice. The company stated it believes Pemgarda has sufficient clinical and post-authorization data to support a Biologics License Application (BLA) submission and approval, though neither HHS nor the FDA has formally provided Invivyd with written guidance on a regulatory approval pathway.

"While an EUA designation granted to Pemgarda by the U.S. FDA in March 2024 has allowed thousands of vulnerable Americans access to a non-vaccine COVID-prevention option for over two years, the EUA designation is not a product approval," said Marc Elia, Chairman of Invivyd's Board of Directors.

Elia added that the company intends to pursue a full BLA approval, citing data from the CANOPY pivotal trial and post-authorization clinical use spanning more than two years.

Under federal law, HHS is required to provide EUA product sponsors with written notice of potential obstacles to product approval and specific actions needed to overcome them. Invivyd noted that as of the announcement date, no such written guidance had been provided by HHS or the FDA regarding a Pemgarda approval pathway.

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